Clinical and Neurocomputational Effects of Behavioral Activation in Veterans With Impaired Social Functioning

NCT07697001 | Not Yet Recruiting

• 1 other identifier: RRD4-009-25W
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Poor psychosocial functioning, including social disconnection, is common and disabling among Veterans, and often fails to improve following the best available evidence-based treatments, particularly if more severe pathology is present. Behavioral activation (BA) is a promising, low-burden intervention, which could help improve social functioning impairments in Veterans, as this treatment targets social reward sensitivity, an important driving mechanism of social functioning. Thus, the proposed research will test whether BA can specifically improve social functioning in Veterans. Leveraging a neurocomputational framework of social reward seeking behavior, this research will help to improve the treatment and assessment of social function and the prediction of psychosocial treatment needs in Veterans, while providing neurobehavioral targets to develop new interventions that can restore social functioning.

Conditions

Social Anhedonia; Social Function Impairment

Keywords

Social Functioning; Social Reward; Anhedonia; Reinforcement Learning; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (5)

• Social Connectedness Scale - Revised (SCS-R)

  Measures the degree to which individuals feel connected to others in their social environment. Scores range from 20 to 120, where higher scores indicate a stronger, healthier sense of social connectedness.

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Inventory of Psychosocial Functioning (IPF)

  The scale measures the degree of impairment in ability to interact effectively with others, fulfill social roles (e.g., work), and meet personal and societal expectations. It is comprised of 7 subscales. Each item ranges from 0 to 6. Higher scores indicate greater degree of impairment in psychosocial functioning.

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Specific Loss of Interest and Pleasure Scale (SLIPS)

  This is a measure of social anhedonia, i.e., hypo-responsiveness to social rewards, such as positive human interactions. Scores range from 0 to 69. Higher scores indicate greater severity of social anhedonia.

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Social Reward Maximization

  Computational parameter derived from behavioral social functioning probe (behavioral reinforcement learning task), capturing the degree to which individuals select social partners they predict to be more rewarding (to offer the most compliments).

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Neural Activation to Social Reward Prediction Errors (RPEs)

  Average BOLD (Blood-Oxygenation-Level Dependent) % signal change (i.e., activation) associated with individuals' model-based RPE (difference between expected probability of reward/compliment and actual outcome received. i.e., compliment vs no-compliment).

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

Secondary Outcomes (6)

• Primary Psychiatric Diagnosis

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• World Health Organization Quality of Life Scale (WHOQOL-BREF)

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• PTSD Checklist-5 (PCL-5)

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Beck Anxiety Inventory (BAI)

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

Other Outcomes (3)

• Reaction to Treatment Questionnaire

  Baseline, Post-Treatment (12-weeks)

• Mood and Anxiety Symptoms Questionnaire (MASQ-D30)

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

• Liebowitz Social Anxiety Scale (LSAS)

  Baseline, Post-Treatment (12 weeks), Follow-Up (24 weeks)

Study Arms (2)

Behavioral Activation (BA)

EXPERIMENTAL

This arm provides the experimental treatment, i.e., Behavioral Activation therapy.

Behavioral: Behavioral Activation (BA)

Supportive Care Therapy (SCT)

ACTIVE COMPARATOR

This arm provides the active control treatment, i.e., Supportive Care Therapy.

Behavioral: Supportive Care Therapy (SCT)

Interventions

Behavioral Activation (BA) BEHAVIORAL

BA is a structured behavioral protocol for depression, designed to help individuals increase engagement in meaningful and rewarding activities, thereby breaking the cycle of avoidance and inactivity that often accompanies depression. The protocol teaches patients to increase a) engagement in pleasant, reinforcing activities, with a strong emphasis on social engagement and social connection, b) exploration of values, and c) goal-setting and goal-directed behavior, while monitoring their mood and daily activities

Behavioral Activation (BA)

Supportive Care Therapy (SCT) BEHAVIORAL

SCT is a Rogerian non-directive approach and employs techniques to convey a deep understanding of emotions, thoughts, and behaviors of the Veterans receiving this treatment. Specific techniques include content-focused paraphrasing, exploration through open-ended questions (with a goal of empathic understanding), and emotion-focused reflection and validation. Consistent with the SCT model, the therapist will be explicitly instructed not to provide advice, assign activities, or suggest strategies and techniques employed in the BA intervention.

Supportive Care Therapy (SCT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being a Veteran
• having moderate to high levels of social disconnection (Social Connectedness Scale-Revised/SCS-R score \< 90)
• having moderate to high levels of social functioning impairments (Sheehan Disability Scale/SDS-social domain score \>=5)
• having moderate to high levels of social anhedonia (Specific Loss of Interest and Pleasure Scale/SLIPS score \>= 6)

You may not qualify if:

• lifetime history of psychotic or bipolar disorder
• neurological conditions, neurodevelopmental disorders, or sensory deficits that may impact cognitive functioning to preclude understanding/completion of study procedure
• regular use of certain psychotropic medications that may significantly impact goal-directed performance on the task (i.e., benzodiazepines, sedative hypnotics, and opioid analgesics); pre-existing stable doses of psychotropic medications, such as SSRIs, will be allowed (if same regimen has been taken for at least 30 days)
• current severe alcohol or substance use disorders (AUD/SUD) necessitating prioritization of substance use treatment
• suicidal or homicidal ideation within the past month necessitating urgent higher-level care
• concurrent individual cognitive-behavioral psychotherapy specifically targeting depression, anhedonia, and/or PTSD

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Anhedonia; Social Adjustment

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Katia Harle, MD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katia Harle, MD

CONTACT

(858) 642-3657; Katia.Harle@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: In this double-blind randomized clinical trials, participants will be randomized to complete one of 2 treatment arms: 1) behavioral activation or 2) supportive care therapy. Participants will complete 8 treatment sessions in either treatment arm.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: IPD and supporting information will become available upon completion of the study and publication of the the results.
• Access Criteria: Final de-identified datasets in machine-readable format will be submitted to and accessed from PubMed Central (and similar sites); care will be taken to ensure that individuals cannot be re-identified using other publicly available information.

Locations

US (1)